Triple Antibiotic Plus Pain Relief
Triple Antibiotic Plus Pain Relief is an FDA drug label for the active ingredient BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE manufactured by Sun Pharmaceutical Industries, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260604.
- Generic name
- BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 51672-2027
- Application
- M004
- Label effective
- 20260604
About this product
Triple Antibiotic Plus Pain Relief is an FDA-registered drug product whose active ingredient is BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE. It is labelled by Sun Pharmaceutical Industries, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51672-2027, application M004, label effective 20260604. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE are most often described in connection with: first aid, help prevent, temporary relief, pain discomfort, minor cuts, scrapes burns. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses first aid to help prevent infection and for the temporary relief of pain or discomfort in minor: cuts scrapes burns
Dosage & Administration
Directions adults and children 2 years of age and older: clean the affected area and dry thoroughly apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage. Children under 2 years of age: ask a doctor
Warnings
Warnings For external use only. Do not use if you are allergic to any of the ingredients in the eyes over large areas of the body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse symptoms persist for more than 1 week, or clear up and occur again within a few days a rash or other allergic reaction develops Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-1047-2020 | Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05 | Sun Pharmaceutical Industries, Inc. | Class II | Terminated | 20200325 |
| D-1033-2020 | Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50. | Sun Pharmaceutical Industries, Inc. | Class II | Terminated | 20200325 |
| D-1032-2020 | Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01. | Sun Pharmaceutical Industries, Inc. | Class II | Terminated | 20200325 |
| D-0787-2020 | Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India | Sun Pharmaceutical Industries, Inc. | Class II | Terminated | 20200122 |
| D-0660-2020 | Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ | Sun Pharmaceutical Industries, Inc. | Class II | Terminated | 20200122 |
Frequently asked questions
What is Triple Antibiotic Plus Pain Relief used for?
Uses first aid to help prevent infection and for the temporary relief of pain or discomfort in minor: cuts scrapes burns
Who makes Triple Antibiotic Plus Pain Relief?
Sun Pharmaceutical Industries, Inc. is the labeler of record for Triple Antibiotic Plus Pain Relief.
What form does Triple Antibiotic Plus Pain Relief come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Triple Antibiotic Plus Pain Relief prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Triple Antibiotic Plus Pain Relief been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.